The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Xsmart Iq.
| Device ID | K161213 |
| 510k Number | K161213 |
| Device Name: | XSmart IQ |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-29 |
| Decision Date | 2017-02-10 |
| Summary: | summary |